Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

Hypertension Clinical Trial

— IBPS  

Official title:

Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03303391
• Other study ID #: STU 032017-024
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• End Stage Renal Disease on Maintenance Hemodialysis

• Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis

Exclusion Criteria:

• Hemodialysis Vintage < 1 month

• Pregnancy

• Nadir Systolic Blood Pressure < 95 mmHg

• Pre or Post dialysis systolic blood pressure > 180 mmHg

• Decrease in systolic blood pressure >60 mmHg from pre to post dialysis

• Ultrafiltration rate >13 mL/kg/hr

• Peridialytic Midodrine Use

• Intradialytic Clonidine use

• Documented Antihypertensive Medication Non-adherence

Bioimpedance will not be peformed on patients with

• amputated arms or legs

• cardiac defibrillator or pacemaker

• presence of metal prostheses

Related Conditions & MeSH terms

• ESRD
• Extracellular Fluid Alteration
• Hypertension

Intervention

Other:
• Intradialytic Blood Pressure Slope Based Ultrafiltration
Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments

Locations

Country	Name	City	State
United States	Davita Dialysis	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Ambulatory Systolic Blood Pressure	The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)	Baseline, 4 months
Secondary	Change in Extracellular Volume/Body Weight Ratio	expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month	Baseline, 4 months